Trial Outcomes & Findings for Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease (NCT NCT00558025)
NCT ID: NCT00558025
Last Updated: 2014-05-16
Results Overview
A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)
COMPLETED
PHASE3
156 participants
from baseline to week 9
2014-05-16
Participant Flow
Participant milestones
| Measure |
Pramipexole Extended Release (ER)
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d. (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Overall Study
STARTED
|
104
|
52
|
|
Overall Study
COMPLETED
|
100
|
49
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
Pramipexole Extended Release (ER)
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d. (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Protocol Violation
|
1
|
0
|
Baseline Characteristics
Overnight Switch Trial From Pramipexole IR to Pramipexole ER in Patients With Early Parkinson Disease
Baseline characteristics by cohort
| Measure |
Pramipexole Extended Release (ER)
n=104 Participants
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
n=52 Participants
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
Total
n=156 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
63.8 Years
STANDARD_DEVIATION 8.8 • n=5 Participants
|
63.5 Years
STANDARD_DEVIATION 9.7 • n=7 Participants
|
63.7 Years
STANDARD_DEVIATION 9.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
68 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
57 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
88 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: from baseline to week 9Population: Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint
A successful switch was defined by no change of the Unified Parkinson's Disease Rating Scale (UPDRS) II+III by more than 15% from baseline to week 9, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)
Outcome measures
| Measure |
Pramipexole Extended Release (ER)
n=103 Participants
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
n=52 Participants
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)
Successfully switched
|
84.5 Percentage of participants
|
94.2 Percentage of participants
|
|
Percentage of Patients Who Successfully Switched From Pramipexole Immediate Release (IR) to Pramipexole ER After a Possible Dose Adaptation, Full Analysis Set (FAS), Last Observation Carried Forward (LOCF)
Not successfully switched
|
15.5 Percentage of participants
|
5.8 Percentage of participants
|
SECONDARY outcome
Timeframe: from baseline to week 4Population: Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint
A successful switch was defined by no change of the UPDRS II+III by more than 15% from baseline to week 4, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment).
Outcome measures
| Measure |
Pramipexole Extended Release (ER)
n=103 Participants
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
n=52 Participants
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)
Successfully switched
|
81.6 Percentage of participants
|
92.3 Percentage of participants
|
|
Percentage of Patients Who Successfully Switched From Pramipexole IR to Pramipexole ER With no Dose Adaptation, FAS (LOCF)
Not successfully switched
|
18.4 Percentage of participants
|
7.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and week 9Population: Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint
Unified Parkinson's Disease Rating Scale part II+III total score on FAS, Week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 160 (worst impairment)
Outcome measures
| Measure |
Pramipexole Extended Release (ER)
n=103 Participants
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
n=52 Participants
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Change From Baseline in UPDRS Part II+III Total Score at Week 9, FAS (LOCF)
|
-1.6 Score on scale
Standard Error 0.5
|
-0.5 Score on scale
Standard Error 0.7
|
SECONDARY outcome
Timeframe: Baseline and week 9Population: Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint
Unified Parkinson's Disease Rating Scale part II total score on FAS, Week 9 - baseline, UPDRS II score ranging from 0 (no impairment) to 52 (worst impairment)
Outcome measures
| Measure |
Pramipexole Extended Release (ER)
n=103 Participants
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
n=52 Participants
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Change From Baseline in UPDRS Part II Total Score at Week 9, FAS (LOCF)
|
-0.3 Score on Scale
Standard Error 0.2
|
-0.1 Score on Scale
Standard Error 0.3
|
SECONDARY outcome
Timeframe: Baseline and week 9Population: Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint
Unified Parkinson's Disease Rating Scale part III total score on FAS, week 9 - baseline, UPDRS II+III score ranging from 0 (no impairment) to 108 (worst impairment)
Outcome measures
| Measure |
Pramipexole Extended Release (ER)
n=103 Participants
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
n=52 Participants
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Change From Baseline in UPDRS Part III Total Score at Week 9, FAS (LOCF)
|
-1.2 Score on Scale
Standard Error 0.4
|
-0.3 Score on Scale
Standard Error 0.6
|
SECONDARY outcome
Timeframe: Week 9Population: Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint
Clinical Global Impression - Improvement on FAS, CGI-I was rated from 1: very much improved, to 7: very much worse, CGI-I responder are defined as being rated as 'unchanged', 'minimally improved', 'much improved', or 'very much improved', CGI-I non-responder are defined as being rated 'minimally worse', 'much worse' or 'very much worse'
Outcome measures
| Measure |
Pramipexole Extended Release (ER)
n=103 Participants
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
n=52 Participants
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)
CGI-I non-responder
|
13 participants
|
11 participants
|
|
Clinical Global Impression - Improvement (CGI-I), FAS (LOCF)
CGI-I responder
|
90 participants
|
41 participants
|
SECONDARY outcome
Timeframe: Week 9Population: Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint
Patient Global Impression - Improvement on FAS, PGI-I was rated from 1: very much better, to 7: very much worse, PGI-I responder are defined as being rated as 'unchanged', 'minimally better', 'much better', or 'very much better', PGI-I non-responder are defined as being rated as 'minimally worse', 'much worse', or 'very much worse'
Outcome measures
| Measure |
Pramipexole Extended Release (ER)
n=103 Participants
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
n=52 Participants
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Patient Global Impression - Improvement (PGI-I), FAS (LOCF)
PGI-I responder (unchanged to very much better)
|
84 participants
|
37 participants
|
|
Patient Global Impression - Improvement (PGI-I), FAS (LOCF)
PGI-I non-responder
|
19 participants
|
15 participants
|
SECONDARY outcome
Timeframe: Week 9Population: Full Analysis Set (FAS), all randomized patients that received treatment and had baseline and post baseline measurements for the primary endpoint
Patients with increase in daily Pramipexole dose on FAS
Outcome measures
| Measure |
Pramipexole Extended Release (ER)
n=103 Participants
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
n=52 Participants
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Pramipexole Dose Adaptation, FAS (LOCF)
Daily dose increased
|
17 participants
|
7 participants
|
|
Pramipexole Dose Adaptation, FAS (LOCF)
Daily dose not increased
|
86 participants
|
45 participants
|
SECONDARY outcome
Timeframe: Week 9Population: Treated Set (TS) includes all patients randomized and who received treatment
The mean final daily Pramipexole dose is displayed
Outcome measures
| Measure |
Pramipexole Extended Release (ER)
n=104 Participants
0.375mg, 0.75 mg, 1.5 mg, 2.25 mg, 3.0 mg, 3.75 mg, 4.5mg, q.d (Quaque die, once per day), per os
|
Pramipexole Immediate Release (IR)
n=52 Participants
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.25 mg, 1.5 mg, t.i.d (Tres in die, three times daily), per os
|
|---|---|---|
|
Final Pramipexole Dose (mg) After 9 Weeks, Treated Set
|
2.75 mg
Standard Deviation 0.95
|
2.83 mg
Standard Deviation 0.86
|
Adverse Events
Pramipexole Extended Release (ER)
Pramipexole Immediate Release (IR)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim Pharmaceuticals
Boehringer Ingelheim Pharmaceuticals
Results disclosure agreements
- Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
- Publication restrictions are in place
Restriction type: OTHER